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ARTICLE | Clinical News

ASIT reports additional Phase III data for gp-ASIT+ in rhinitis

July 21, 2017 6:45 PM UTC

ASIT biotech S.A. (Euronext:ASIT) reported additional data from the double-blind, international Phase III BTT009 trial in 554 patients with grass pollen-induced allergic rhinitis with or without controlled asthma showing that once-weekly subcutaneous gp-ASIT+ for a cumulative dose of 170 µg in 3 weeks met the primary endpoint of improving mean Combined Symptom and Medication Score (CSMS) for the daily total Rhinoconjunctivitis Symptom Score (RTSS) and the daily Rhinoconjunctivitis Medication Score (RMS) vs. placebo (p<0.05). However, the company said the results cannot be regarded as confirmatory because gp-ASIT+ did not achieve the predefined 20% difference in CSMS compared to placebo.

gp-ASIT+ significantly improved CSMS by 15.5% during the peak pollen period (p=0.04) and by 17.9% during the entire pollen season (p=0.03) vs. to placebo. In a subgroup of patients with Conjunctival Provocation Test (CPT) reactivity scores at baseline of 3 and 4 points, gp-ASIT+ significantly improved symptoms by 20% during the peak pollen period (p=0.05) and by 24% (p=0.05) during the entire pollen season (p=0.05) vs. placebo. Data were presented at the European Academy of Allergy and Clinical Immunology meeting in Helsinki...

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